About 40 percent of women may have breast tissue too dense for mammography to work.

Photo: Liz Hafalia, The Chronicle

About 40 percent of women may have breast tissue too dense for...

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Dr. Dipa Patel (right), a breast imaging specialist in Los Gatos, has both a mammography unit and a U-Systems automated ultrasound. She charges around $250 for an automated ultrasound.

Photo: Liz Hafalia, The Chronicle

Dr. Dipa Patel (right), a breast imaging specialist in Los Gatos,...

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Dr. Dipa H. Patel showing images by the Automated Breast Ultrasound system (ABUS, at far right) used for 3D breast ultrasound which has FDA approval for screening women with dense breasts at Breast Imaging Specialists in Los Gatos, Calif., on Tuesday, September 25, 2012. At middle left are 3D mammography digital images.

A new law that will require California doctors to tell women if they have highly dense breast tissue is expected to increase demand for alternatives to mammography to screen patients for breast cancer.

The potential market is huge: About 40 percent of women have tissue that is dense enough that cancer may be missed through conventional mammography. The law says that beginning in April, patients must be told a "range of screening options" are available, but it does not specify those methods or require health insurers to cover them.

Demand for those alternatives is likely to increase as more and more women start receiving letters telling them that the mammogram they just received may not be the best detection tool for them.

"It will be a technology driver," said state Sen. Joe Simitian, D-Palo Alto, author of the bill, which Gov. Jerry Brown signed last weekend. "As we shine a bright light on limitations of the existing technologies, people will move forward to develop and improve technologies that are more effective for the 40 percent of women who have dense breasts."

Nearly 40 million mammograms are performed each year in the United States, which means the potential market for alternative screening methods could be about 18 million. Such methods include 3-D mammography, gamma imaging, hand-held and automated ultrasounds and, in women with an extremely high chance of getting cancer, breast magnetic resonance imaging, or MRI.

A growing trend

California follows Connecticut, Texas, Virginia and New York in requiring breast density notification. Similar legislation is being considered in about a dozen other states as well as in Congress.

Brown vetoed a similar bill by Simitian last year amid concerns from physician groups that the law would give women worrisome and confusing information, lead to unnecessary biopsies and increase health costs. Changes in the language of this year's bill satisfied the critics, who dropped their formal objections.

Debate continues over which technology will fill the demand and how effective those methods will be in saving lives. Most experts agree that automated ultrasound - which can be done by a technician and later read by a physician - is emerging as a promising option because it's relatively cost effective, convenient and can offer an objective reading.

Last week, U-Systems, a Sunnyvale company that makes an automated breast ultrasound, became the first to receive U.S. Food and Drug Administration approval for a device to be used as a screening tool for dense breasts.

"There's going to be a huge demand for the product as women are told by physicians that mammography is an imperfect tool to see (through) dense tissue," said Ron Ho, president and chief executive officer of U-Systems.

Another ultrasound option

The automated ultrasound costs between $180,000 and $250,000 - about half the price of a digital mammogram unit - and patients are typically charged $200 to $300 per screening if it's not covered by insurance, Ho said.

Another ultrasound company, SonoCiné in Reno, offers an automated breast ultrasound that can connect to a standard ultrasound system. The system, which has received certification for use as an adjunct to mammography by the federal government, costs about $185,000 per unit, but the company also charges per procedure in lieu of purchasing the unit.

The company's president, Roger Royce, said he expects doctors will start using these new options as demand increases and that insurers will start paying for these screenings. Connecticut, which in 2009 became the first state to enact a density notification law, is the only state to require insurers to cover alternative screenings.

Some California doctors are ahead of the curve in offering the option.

More information

"They both complement the exams and give slightly different information," Patel said, adding that she can detect almost all cancers with few false positives. She said she charges about $250 for the automated ultrasound and that sometimes insurers will cover it.

Sutter Women's Health Center in Santa Rosa has been notifying patients about their breast density since December 2010, when it started using the SonoCiné automated system.

Dr. Dennis McDonald, medical director of women's imaging, said the center early this year dropped its automated ultrasound price from $250 to $179.

"As it isn't currently covered by insurance, there will be some patients that will want it and don't have the means to do it," he said. "It should be priced so this is available to as many women as possible."

Breast density law

About 40 percent of the women who have mammograms have dense breast tissue, which can make cancerous tumors difficult to detect on a mammogram. A new California law requires that beginning April 1, after getting a mammogram, women with dense breast tissue be informed that:

-- They have dense breast tissue;

-- That dense breast tissue can make it harder to evaluate the results of a mammogram and that it is associated with an increased risk of breast cancer;

-- That information about breast density is available from their doctor and that a range of screening options are available.